Clinical Deployment and Validation of Rho

N/A

Recruiting

Led By Anastasia Oikonomou, MD, PhD

Research Sponsored by 16 Bit Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a software called RhoTM that looks at x-rays to find people with weak bones. It targets older patients because they are more likely to have bone issues. The software helps doctors decide if more tests are needed to check for osteoporosis.

Eligible Conditions

Osteoporosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positive predictive value

Secondary study objectives

DXA conversion

Other study objectives

Fracture risk assessment tool (FRAX) scores

Radiologist adoption

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Opportunistic screening for low BMDExperimental Treatment1 Intervention

Outpatients aged over 50 years undergoing x-ray of the thoracic spine, lumbar spine, chest, pelvis, hand or knee will have their x-rays screened for low BMD by the software-as-a-medical device. If low BMD is identified by the software, a radiologist reviewing the x-ray may choose to incorporate this as an incidental finding in their report to the referring physician.

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